The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2398-2020·Announced 2020-06-24

AngioDynamics Recalls PICC Kits Containing Recalled BD Saline Flush Syringes

AngioDynamics is recalling BioFlo and Xcela PICC kits because they contain BD saline flush syringes that were previously recalled by BD Medical.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a precautionary measure to remove kits containing components that were previously recalled by another manufacturer. The source text does not report any illnesses, injuries, or deaths associated with this specific recall, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

AngioDynamics, Inc. is recalling certain BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits. The recall is necessary because these kits contain BD PosiFlush SF Saline Flush Syringes that were recalled by BD Medical on April 16, 2020.

The affected products are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including the administration of fluids, medications, and nutrients, blood sampling, and power injection of contrast media. The recall covers 119,723 units distributed nationwide in the United States.

Healthcare providers and facilities should check their inventory for the specific item numbers and lot numbers listed in the official recall notice. Units from specific lots marked with an asterisk in the source data are noted as being within AngioDynamics control and not distributed, and are therefore removed from the recall notification.

The recalled product

Product
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the…
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — PICC Kits
Hazard
Affected units
119,723

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • therefore
  • removed from recall notification.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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